Cosmetic composition and method for retarding hair growth

ABSTRACT

The present invention comprises cosmetic compositions and methods for retarding hair growth comprising a combination of an ornithine decarboxylase inhibitor, an anti-angiogenic active and an anti-inflammatory.

This application claims priority of U.S. provisional application60/535,125 filed Jan. 7, 2004.

FIELD OF THE INVENTION

The present invention relates to skin care cosmetic compositions andmethods. In particular, the present invention relates to novel cosmeticcompositions and methods for retarding hair growth.

BACKGROUND OF THE INVENTION

For years, companies have marketed products for either hair growth orhair growth retardation, with limited success. From mechanicalprocedures to compositions containing biologically active ingredients,numerous means are available for the consumer. Use of hair dyes to colorhair, require frequent repetitions and are not often effective in hidingthe appearance of hair on the skin.

Especially in suppressing hair growth, the prior art has taught the useof numerous actives including biological enzymes, plant extracts andenzyme inhibitors. For example, U.S. Pat. No. 6,375,948 teaches the useof an extract of a plant of the family Juniperus or a malt, an elastaseinhibitor or neutral endopeptidase inhibitor and a proteolytic enzyme tosuppress hair growth. In U.S. Pat. No. 6,407,056, the patent teaches amethod of delaying mammalian hair growth comprising topically applyingan effective amount of a composition comprising a serine protease and apharmaceutically or cosmetically acceptable vehicle.

The references discussed above have limited and only short termusefulness. Other references turn to the factors that are believed tocontribute to hair growth to develop formulas for regulating hairgrowth.

For example, angiogenesis is the fundamental process by which new bloodvessels are formed. The process involves the migration of vascularendothelial cells into tissue, followed by the condensation of suchendothelial cells into vessels. Angiogenesis involves a complexinterplay of molecules that stimulate and molecules that inhibit thegrowth and migration of endothelial cells. In U.S. Pat. No. 6,391,850,it was found that an anti-angiogenic, SLED, stimulated the growth ofhair. It was believed that SLED affected hair growth by mediatingangiogenesis within the hair follicle.

Sphingo Glycolipids, such as phytosphingosine (known to be ananti-angiogenic), have been used in skin care compositions to aid inhair growth. For example, U.S. Pat. No. 5,565,207 (“patent '207”)teaches the use of a scalp moisturizer comprising a steroid glycosideand/or a triterpenoid glycoside, a sphingo glycolipid and a follicularhormone and/or an adrenocortical hormone. Patent '207 recognizes the useof the scalp moisturizer to stimulate hair growth.

It is important to note that the references discussed above teach theuse of anti-angiogenics to aid in promoting hair growth.

Yet another factor believed to contribute to hair growth is OrnithineDecarboxylase (OCD), an enzyme that catalyzes the decarboxylation ofornithine to putrescine. The reaction is the first step in thebiosynthesis of the polyamides known as spermidine and spermine. Thepolyamides are known to play an important role in cell growth andproliferation. U.S. Pat. No. 4,720,489 (“patent '489”) teaches the useof ornithine decarboxylase inhibitors to retard hair growth. Patent '489specifically teaches against the use of certain ornithine decarboxylaseinhibitors that can have secondary pharmacological effects.

In summary, the references discussed above teach that anti-angiogenicagents promote hair growth while certain ornithine decarboxylaseinhibitors retard hair growth. Still other references teach compositionswith only limited efficacy.

There still remains a need for a novel composition and method forinhibiting hair growth that has prolonged efficacy that can beaccomplished preferably by manipulating the numerous factors thatcontribute to hair growth.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1. Chart depicting results of Self Assessment of product containinginventive composition of the present invention from the Clinical Studyin Example 1.

FIG. 2. Chart depicting results of product evaluation after eight weeksof use from the Clinical Study in Example 1.

FIG. 3. Chart depicting results of image analysis of clinical study inExample 1 using inventive composition of the present invention.

FIG. 4. Chart depicting results of comparative study between inventivecomposition and conventional hair growth retardation product.

SUMMARY OF THE INVENTION

The present invention comprises a cosmetic composition comprising from0.1 to 50% of an ornithine decarboxylase inhibitor, from 0.01 to 10% ofan anti-angiogenic active, from 0.0001 to 20% of an anti-inflammatoryand a cosmetically acceptable vehicle.

The present invention further comprises a method of retarding hairgrowth comprising applying a composition comprising from 0.1 to 50% ofan ornithine decarboxylase inhibitor, from 0.01 to 10% of ananti-angiogenic active, from 0.0001 to 20% of an anti-inflammatory and acosmetically acceptable vehicle.

DETAILED DESCRIPTION

Except in operating and comparative examples, or where otherwiseexplicitly indicated, all numbers in this description indicating amountsor ratios of material or conditions of reaction, physical properties ofmaterials and/or use are to be understood as modified by the word“about.” All amounts are by weight of the final composition, unlessotherwise specified.

It has been surprisingly discovered that the combination of an ornithinedecarboxylase inhibitor with an anti-angiogenic active and ananti-inflammatory effectively suppresses hair growth.

In a preferred embodiment, the ornithine decarboxylase inhibitor isderived from a marine, synthetic, or naturally derived source as opposedto an animal derived source. Preferred inhibitors are pentacyclictriterpenes. Examples of pentacyclic triterpenes include ursolic acid,betulin, betulinic acid, oleanolic acid, betulin mono and di-succinateor glutarate. Particularly preferred is ursolic acid extracted fromRosmarinus officinalis, which is commercially available from SabinsaCorporation in 121 Ethel Road West, Unit #6, Piscataway, N.J. 08854.

The amount will vary depending on the formulation and the performancedesired. The ornithine decarboxylase inhibitor is used in an amount from0.001% to 90% by weight of the composition is used. Preferably, anamount of from 0.001% to 60% is used and most preferably, an amount offrom 0.01% to 3% is used.

The preferred composition further comprises an anti-angiogenic active.Although anti-angiogenic agents have been known to promote hair growth,it has been surprisingly found that an anti-angiogenic can aid in theinhibition of hair growth in the present inventive combination.Particularly preferred anti-angiogenics include sphingo lipids. Examplesof sphingo lipids include phytosphingosine, dihydrosphingosine,sphingosine, dehydrophytosphingosine, monohexosylceramide,sphingoplamalogen, acetyl sphingosine and monohexaosylceramide fattyacid ester. Other anti-angiogenic agents include magnolia extract, MDIcomplex (shark cartilage) and tetrahydrocurcumin and extracts of greentea.

The amount will vary depending on the formulation and the performancedesired. In general, the anti-angiogenic is used in an amount from0.001% to 90% by weight of the composition is used. Preferably, anamount of from 0.01% to 60% and most preferably, an amount of from 0.1%to 2% is used.

Inflammation and related irritation can detrimentally interfere with theability of actives to penetrate the skin and provide their intendedbenefit. Anti-inflammatories have been used in hair growth compositionsto enhance the activity of hair growth promoting actives (See U.S. Pat.No. 6,451,777). However, in the present invention, it has beensurprisingly discovered that an anti-inflammatory when combined with anornithine decarboxylase inhibitor and an anti-angiogenic agent actuallyaids in inhibiting hair growth.

The anti-inflammatory used in the present invention can be selected fromany known in the art. A particularly preferred anti-inflammatory isgorgonian extract. Gorgonian extract is a marine-derived, naturalextract available from the Lipo Chemical Company, Patterson, N.J. as aliquid extract of Sea Whip, pseudopterogorgia elisabethae, supplied as a4% Sea Whip extact in butylene glycol. The Caribbean Sea Whippseudoptemgorgia elisabethae has been reported in Proc. Natl. Acad. Sci.USA, Vol. 83, pp. 6238-6240 (September 1986) as containingpseudopterosins which are diterpene-pentose glycosides. U.S. Pat. No.4,849,410 and U.S. Pat. No. 4,745,104, incorporated by reference herein,provide further disclosure on the Caribbean gorgonians. Alternatively,anti-inflammatories such as boswellin, hoelen extract, ximenynic acid,hesperitin, tea polyphenols and licorice extract may be used.

The amount will vary depending on the formulation and the performancedesired. Specifically, amounts of an anti-inflammatory such as gorgonianextract for purposes of this invention will range from 0.00001% to 20%,preferably from 0.0001% to 5%, and most preferably from 0.1% to 1% byweight.

It has been surprisingly found that hair growth can be significantlyinhibited by addition of a 5 alpha reductase inhibitor to the inventivecombination. It is known that 5 alpha reductase promotes the formationof 5 dihydrotestosterone (DHT), a product of testosterone. DHT is thehormone in skin that stimulates hirsutism, which is male pattern hairgrowth. It is believed that reducing DHT can result in reduction ofhirsutism or male pattern hair loss. Therefore, inhibiting the formationof 5 alpha reductase is believed to prevent the formation of DHT andtherefore prevent hirsutism and prevent male pattern hair loss.Surprisingly, however, it is believed that combining a 5 alpha reductaseinhibitor with the presenting inventive composition helps retard hairgrowth in all areas of the body, including areas with typical malepattern hair loss, as shown in Example 3 below.

Suitable 5 alpha reductase inhibitors include inhibitors commonly knownin the art and include but are not limited to saw palmetto, woodworm(Artemisinin), liposome encapsulated azuleic acid (Azelosome), cloveextract (Chouji Liquid), Zinc salt of L-Pyrrolidone Carboxylic Acid(Zincidone®), mixture of water, hydrolyzed soy protein, 3-aminopropane,sulfonic acid and sodium chondroitin sulfate (Capigen), seaweed extract(Phlorogine), isolutrol, progesterone, (5,20-R)-4-diazo-21-hydroxy-20-methyl pregnan-3-one,(4R)-5-10-seco-19-Norpregna4,5-diene-3,10,20 trione,4-androstene-3-one-17-carboxylic acid, and its methyl ester,17-beta-N,N-diethylcarbamoyl-9-methyl-4-aza-5-alpha-androstane-3-one,11-alpha-OH-progesterone, 17-alpha-OH-progesterone, and20-alpha-OH-progesterone.

The amount will vary depending on the formulation and the performancedesired. Preferably, the 5 alpha reductase inhibitor is saw palmetto andis present in the amount from 0.0001% to 10%, more preferably from0.001% to 5% and most preferable from 0.01% to 1%.

In yet another alternate preferred embodiment, the appearance of haircan be further reduced by the addition of a whitening agent in theinventive formulations. Suitable whitening agents include yeast extract(Yeast AE), ferulic acid, BV-OSC (vitamin C derivative from Barnet), Na+hinokitiol, licorice extract (glabridin), etioline (extract ofmitracarpus & bearberry in combination with glycerin and butyleneglycol), phytoclar II (mulberry & scutellaria from Coletica), arbutin,resveratrol and kojic acid. Particularly preferred is glabridin obtainedfrom Alchem Internationl Ltd., at 201, Empire Plaza, Mehrauli-GurgaonRoad, Sultanpur, New Delhi, India.

The amount will vary depending on the formulation and the performancedesired. Preferably, the whitening agent is present in the amount from0.0001% to 20%, more preferably from 0.001% to 15% and most preferablefrom 0.01% to 10%.

It is believed that a component with estrogen-like activity maysurprisingly aid in compositions for the retardation of hair growth.Therefore, in an alternate preferred embodiment, the present inventionfurther comprises an estrogen-like component. Particularly preferredsupplements are plant extracts such as solgen-40 C (a soy extract), wildyarn and ginseng or phytoestrogens derived therefrom. Particularlypreferred is solgen-40 C obtained from Solbar Hatzor Ltd. located inKibbutz Hatzor, P.O. Box 2230, Ashdod, Israel, 77121.

The amount will vary depending on the formulation and the performancedesired. Preferably, the plant extract is present in an amount of0.0001% to 25%, more preferably from 0.001% to 15% and most preferablyfrom 0.01% to 10%.

In yet another preferred embodiment, the present inventive compositionmay contain conventional hair removal ingredients (such asthioglycollate) in any amount desired as would be compatible with thepresent composition. A list of conventional hair removal ingredients canbe found in the International Cosmetic Ingredient Dictionary, CTFA,Sixth Edition, 1995.

The composition further comprises a cosmetically acceptable vehicle thatis suitable for topical application to skin, hair and/or nails.Cosmetically acceptable vehicles are well known in the art and areselected based on the end use of the application. For example, vehiclesof the present invention include, but are not limited to, those suitablefor application to the skin. Such vehicles are well known to those ofordinary skill in the art, and can include one or more compatible liquidor solid filler diluents or vehicles which are suitable for applicationto the skin. The exact amount of vehicle will depend upon the level ofany other optional ingredients that one of ordinary skill in the artwould classify as distinct from the vehicle (e.g., other activecomponents). The compositions of the present invention preferablycomprise from about 40% to about 99.99%, more preferably from about 70%to about 99.99%, and most preferably from about 80% to about 98%, byweight of the composition, of a vehicle.

The vehicle and the compositions herein can be formulated in a number ofways, including but not limited to emulsions. For example, suitableemulsions include oil-in-water, water-in-oil, water-in-oil-in-water,oil-in-water-in-oil, and oil-in-water-in-silicone emulsions. Preferredcompositions comprise an oil-in-water emulsion.

The compositions of the present invention can be formulated into a widevariety of product types, including shampoos, creams, waxes, pastes,lotions, milks, mousses, gels, oils, tonics and sprays. Preferredcompositions are formulated into lotions, creams, gels, shampoos andsprays. These product forms may be used for a number of applications,including but not limited to, hand and body lotions, cold creams, facialmoisturizers, anti-acne preparations, topical analgesics,make-ups/cosmetics including foundations, eyeshadows, lipsticks and thelike. Any additional components required to formulate such products varywith product type and can be routinely chosen by one skilled in the art.

If compositions of the present invention are formulated as an aerosoland applied to the skin as a spray-on product, a propellant is added tothe composition. Examples of suitable propellants includechlorofluorinated lower molecular weight hydrocarbons. A more completedisclosure of propellants useful herein can be found in Sagarin,Cosmetics Science and Technology, 2nd Edition, Vol. 2, pp. 443-465(1972).

Other Components

The formulation also can comprise other components that may be chosendepending on the carrier and/or the intended use of the formulation.Additional components include, but are not limited to, water solublesunscreens (such as Eusolex 232); oil soluble sunscreens (such as octylmethoxycinnamate); and organic sunscreens (such as camphor derivatives,cinnamates, salicylates, benzophenones, triazines, PABA derivatives,diphenylacrylate derivatives, and dibenzoylmethane derivatives.);antioxidants (such as BHT); chelating agents (such as disodium EDTA);emulsion stabilizers (such as carbomer); preservatives (such as methylparaben); fragrances (such as pinene); flavoring agents (such assorbitol); humectants (such as glycerine); waterproofing agents (such asPVP/Eicosene copolymer); water soluble film-formers (such ashydroxypropyl methylcellulose); oil-soluble film formers (such ashydrogenated C-9 Resin); moisturizing agents, such as cholesterol;cationic polymers (such as Polyquatenium 10); anionic polymers (such asxanthan gum); vitamins (such as tocopherol); and the like.

The compositions can also encompass one or more active components, andas such can be either cosmetic or pharmaceutical compositions. Examplesof useful actives include, but are not limited to, those that improve oreradicate age spots, keratoses and wrinkles, analgesics, anesthetics,anti-acne agents, antibacterials, antiyeast agents, antifungal agents,antiviral agents, antidandruff agents, antidermatitis agents,antipruritic agents, antiemetics, antihyperkeratolytic agents, anti-dryskin agents, antiperspirants, antipsoriatic agents, antiseborrheicagents, hair conditioners and hair treatment agents, antiaging agents,antiwrinkle agents, antiasthmatic agents and bronchodilators, sunscreenagents, antihistamine agents, depigmenting agents, wound-healing agents,vitamins, corticosteroids, tanning agents or hormones. More specificexamples of useful active agents include retinoids such as retinol, andesters, acids, and aldehydes thereof; ascorbic acid, and esters andmetal salts thereof, tocopherol and esters and amide derivativesthereof; shark cartilage; milk proteins; alpha- or beta-hydroxy acids;DHEA and derivatives thereof; topical cardiovascular agents;clotrimazole, ketoconazole, miconozole, griseofulvin, hydroxyzine,diphenhydramine, pramoxine, lidocaine, procaine, mepivacaine,monobenzone, erythromycin, tetracycline, clindamycin, meclocyline,hydroquinone, minocycline, naproxen, ibuprofen, theophylline, cromolyn,albuterol, hydrocortisone, hydrocortisone 21-acetate, hydrocortisone17-valerate, hydrocortisone 17-butyrate, betamethasone valerate,betamethasone diproprionate, triaminolone acetonide, fluocinonide,clobetasol, proprionate, benzoyl peroxide, crotamiton, propranol,promethazine, and mixtures thereof.

Particularly preferred embodiments of the present formulations aremoisturizing after-shaves. To that end, the present formulations arecombined with agents that are moisturizers, emollients or humectants.Examples of useful combinations are oils, fats, waxes, esters, fattyacid alcohols, fatty acid ethoxylates, glycols, sugars, hyaluronic acidand hyaluronates, dimethicone, cyclomethicone, and the like. Furtherexamples can be found in the International Cosmetic IngredientDictionary, CTFA, Sixth Edition, 1995.

Method of Retardation of Hair Growth

The present inventive compositions are particularly useful as hairgrowth retardation products. The present inventive compositions andmethods of the present invention provide a unique combination thatsurprisingly retards hair growth. Hair growth can be retarded on theface including eyebrows, upper lips, and sideburns, on the bodyincluding legs, ears and back, and any other area of the body whereundesired hair growth may occur. The present inventive compositions areparticularly preferred to prevent hair growth after shaving.

The present inventive method comprises administering or topicallyapplying to the skin a safe and effective amount of the combination ofthe present invention. The amounts of the components in the compositionswill vary widely depending upon the level of hair growth already inexistence in the subject (if such exists), the rate of further hairgrowth, and the level of regulation desired.

A preferred amount of cosmetically or pharmaceutically treating the skinis via chronic topical application of a safe and effective amount of thenovel composition to regulate hair growth. The amount of the compositionand the frequency of topical application to the skin can vary widely,depending upon the rate of hair growth for the individual. It is wellwithin the purview of the skilled artisan, such as a dermatologist orother health care provider, to regulate pharmaceutical dosages accordingto patient needs. The method of the present invention is particularlyuseful after shaving.

It is suggested as an example that topical application range from aboutonce per week to about 4 or 5 times daily, preferably from about 3 timesa week to about 3 times daily, most preferably about once or twice perday. In a preferred embodiment, the present method is utilized as anaftershave and can be applied directly to the face after shaving. Thecompositions will comprise from about 0.001% to 5%, preferably fromabout 1% to 5%, and most preferably from about 1% to 4% of the activecomponents.

The following examples further illustrate the invention, but theinvention is not limited thereto.

EXAMPLE 1 Clinical Study

A composition comprising the preferred embodiment was applied on theface of male volunteers and evaluated for its ability to make beard hairless noticeable by retarding hair growth, lightening facial hair orreducing the appearance of 5 o'clock shadow.

Study Design:

1. Subject Selection/Inclusion Criteria:

Fourteen men with normal to heavy and dark facial (beard) hair, who arein good general health and free of any dermatological disorders, werequalified for this study.

2. Clinical Protocol:

At every visit the men arrive at the lab between 7-8 am without shaving.They bring their razor with a new blade and regular shave product andshave at the lab. Immediately after shaving, closeness of shave isdocumented by taking close-up photographs with the digital camera. Thesubjects return to the lab after 8 hours and 24 hours and arephotographed again to document 5 o'clock shadow and 24 hour beard hairgrowth.

At the end of the first visit the subjects are given a productcontaining the inventive composition of the present invention(hereinafter “Product”), which they use 2 times a day for 4 weeks. Forthe duration of this study the subjects are asked to use the same shaveproduct every time they shave. They are instructed not to use theproduct on the day of testing. The subjects are given a very briefquestionnaire at every 8 and 24 hour time point to evaluate beardtexture, color, and appearance. At the end of the study they are givenmore a comprehensive questionnaire to evaluate the product. At Weeks 1,2, 4 and 8 the subjects return for testing and the above procedures arerepeated every time. 3. Composition: Ceteareth-12 Eumulgin B-1 3.2%PEG-10 Soya Sterol Generol 122   1% Sorbitan Sesquioleate Arlacel 83V0.1% Glyceryl Stearate SE Glyceryl Monostearate 2.6% 24 SECoco-Caprylate/Caprate Cetiol LC   3% Stearic Acid Dermofat 4919 0.1%Stearyl Alcohol/ Promulgen G-CG 0.5% Ceteareth-20 Hydrogenated LecithinLecinol S-10 0.1% Cholesterol NAB Cholesterol 0.2% Glycereth-26 LiponicEG1 0.2% Octyldodecanol Eutanol G NF 0.1% PhytoshingosineDS-Phytosphingosine 0.1% Purified Water Deionized Water 68.546%  Disodium EDTA Disodium EDTA/Trilon BD 0.1% Phenoxyethanol/Chlorphenesin/ Glycerin/Methyl Paraben/ Benzoic Acid Germazide MPB   1%Potassium Sorbate Sorbistat K 0.1% Methylparaben Methyl Paraben NF0.35%  Pemulen TR-1   5% (2% Disp in MethylP) (Deionized water 4.8925%Pemulen TR-1 Acrylates/C10-30 Alkyl Acrylate Crosspolymer 0.1% MethylParaben Methyl Paraben NF 0.0075%) Purified Water (97.85%) DeionizedWater   4% Polyquaternium-10 (2%) Polymer LR-400 (UCARE) 0.004% Butylene Glycol (0.15%) 1,3 Butylene Glycol   5% Glycyrrhiza GlabraGlabridin 0.05%  (Licorice) Extract Ursolic Acid Ursolic Acid 90% 0.2%Cyclomethicone Dow Corning 245 Fluid   2% Hyaluronic Acid (1% SOL) 0.5%(Purified Water (98.10%) Deionized Water 0.4905%   Sodium Hyaluronate(1%) Sodium Hyaluronate HMW 0.005%  Phenoxyethanol (.70%) Emeressence1160 0.0035%   (Rose Ether) Yeast Extract Yeast Extract AE   1% SoyIsoflavones/ Solgen 40 0.2% Butylene Glycol Sea Whip Extract GorgonianExtract BG/NP 0.5% Phenoxyethanol Emeressence 1160 0.25%  (Rose Ether)Data Analysis:

Self-assessment and product evaluation questionnaires are compiled andthe average results are shown on Tables 1-2 and FIGS. 1-2. Beard growthis evaluated from the digital photographs via image analysis. A templateof the right and left side of the face of each subject is made and theamount of beard hair within this area is measured at each time point.The amount of hair covering the outlined area is directly related tohair length and therefore to hair growth.

Results:

The results of this study show that topical treatment with a productcontaining the above composition is effective in improving beardtexture, color and appearance and reducing beard growth. Table 1 belowand FIG. 1 summarize the results of the study. TABLE 1 Self Assessmentof Beard % Improvement of Texture, Color and Appearance 8 hours aftershaving 24 hours after shaving 1 Wk 2 Wks 4 Wks 8 Wks 1 Wk 2 Wks 4 Wks 8Wks TEXTURE 18.8 27.1 27.8 35.4 13.5 29.1 32.1 28.7 COLOR 19.4 30.1 38.649.0 9.1 27.5 32.5 25.6 APPEARANCE 23.8 27.4 32.1 43.6 15.0 30.2 31.325.6

As seen from Table 1 above and corresponding FIG. 1, self-assessment ofbeard texture, color and appearance at 8 and 24 hours after shavingclearly show an improvement with product use. After 1 week of treatmentthere was about a 20% improvement in texture, color and appearance of 5o'clock shadow (8 hours after shaving) and it increased to about 35-50%after 8 weeks of treatment. At the 24 hour time point there was a 10-15%improvement after 1 week of treatment and increased to 25-30% between 2and 8 weeks of treatment.

User's assessment of product's performance after 8 weeks of use areshown below. The users were asked to comment on the reduction of 5o'clock shadow, beard growth, rate the product and likelihood topurchase it. Table 2 below and corresponding FIG. 2 summarize theseresults. TABLE 2 Evaluation of Beard Growth Retardant Product after 8Weeks of use Results based on a scale from 1 (Poor)-10 (Excellent)Comment Average Score S.D. Reduce appearance of 5 o'clock shadow 5.2 2.4Reduce beard growth 5.0 2.2 Likelihood to buy a product like this 5.13.7 Rate this product 4.9 3.3

As seen in Table 2 above and FIG. 2, on a scale of poor (1) to excellent(10) the participants rated the composition about a 5.

Beard growth is evaluated via image analysis from close up digitalphotographs. These results show that the composition was very effectivein reducing beard growth. Table 3 below and corresponding FIG. 3summarize these results. TABLE 3 Evaluation of Beard Growth RetardantProduct from Digital images via Image Analysis % Decrease in beardgrowth Time after shaving 1 Week 2 Weeks 4 Weeks 8 Weeks Immediately48.0 52.9 41.5 51.8 8 hours 48.1 73.1 77.6 83.0 24 hours 38.8 68.3 52.440.6

As seen from Table 3 above and corresponding FIG. 3, after one week andup to 8 weeks of treatment there is a 40-50% beard reduction immediatelyafter shaving, thereby indicating a closer shave. The best results areseen 8 hours after shaving at the 5 O'clock shadow, where after one weekof treatment there is a 48% reduction in beard growth and it steadilyimproves to 83% after 8 weeks. Twenty four hours after shaving there isa 38-68% reduction in beard growth after 1-8 weeks of treatment withsome variation in the data.

Based on the results of the study in the above Example 1, it is seenthat topical treatment with the composition is effective in improvingbeard texture, color and appearance and reducing beard growth.

EXAMPLE 2 Comparative Study

The following example provides a clinical study comparing an embodimentof the present invention with a conventional hair growth retardationproduct, using a control to note the differences.

Formation of Study Panel:

Adult women are recruited from a local population. The followingcriteria for inclusion and exclusion are based on the informationobtained from the candidates and from an examination of the area that isinvolved in the study.

Inclusion Criteria: To be considered as a potential subject, eachcandidate must:

-   -   shaved legs daily    -   express willingness to cooperate with the investigator;    -   convince the investigator that she was dependable and would        comply with the study regimen;    -   demonstrate the ability to understand the purpose of the study        and what was required of her to bring the study to a meaningful        conclusion;    -   demonstrate the ability to understand the risks associated with        participation; and    -   demonstrate the ability to read and understand all the items in        the informed consent document.        Exclusion Criteria: A prospective participant is excluded if the        interview or examination disclosed any of the following:    -   a systemic illness that contra-indicates participation;    -   any dermatological disorders in the areas that are to be used in        the study;    -   pregnant women or lactating mothers;    -   using systemic or topical retinoids, antihistamines or similar        agents.        Composition of Panel:        19 women who satisfy all the requirements itemized in the list        of inclusion and exclusion criteria.        Test Products:        Product A: Inventive Composition (hereinafter “Hair Growth        Retardation Complex”)    -   Soy Extract (0.2% Solgen 40)    -   Phytospingosine 90.1%)    -   Gorgonian Extract (0.5%)    -   Yeast AE (1%)    -   Ursolic Acid (0.2%)    -   Glabridin (0.05%)        Product B: Conventional Hair Growth Retardation Product    -   Sanguisorba Officinalis Root Extract        Product C: Traditional Moisturizer (Control)        Method of Application:

The women are instructed to apply the products to their legs three timesa day, morning, afternoon, and evening, for 8 weeks. Group 1 appliesproduct A to the right leg and product C to the left leg. Group 2applies product B to the right leg and product C to the left leg. On theday of testing, the women do not apply the products for at least 12hours before measurements were taken. Product use is monitored by adaily diary as well as assessment of remaining package content at theend of the study.

Clinical Test Procedure:

This is a double blinded study consisting of eight weeks of product use.The legs are the test site. The panelists refrain from using anytreatment products on the test sites except for the test productsprovided. The panelists are instructed to shave their legs four daysprior to each visit. Evaluations are carried out before productapplication (baseline), and at two, four, and eight weeks during thecourse of treatment. The panelists report to the Testing Center fortesting.

Test Procedure:

1. Reduction of Hair Growth

At the outset of the study a particular area on the legs of eachpanelist demonstrating four days of hair growth is marked. The images ofthat specific portion of the leg are obtained using a fiber opticmicroscope (Hi-Scope, Vacaville, Calif.) at a magnification of 40×(approximately 1 sq. cm.) Ten sites are chosen per leg per panelist. Thesame area is photographed at each time point following the initialvisit. The stored images are digitized and analyzed using an imageanalysis program, Optimas 6.51. The average hair length is calculatedusing total area 4 days after shaving at each time point to determinethe amount of hair growth.

2. Results TABLE 4 Comparative Study Results Time Point Average %Reduction p-value Hair Growth Retardation Product Baseline 0.97 2 weeks0.83 14% p > 0.05 4 weeks 0.82 16% p > 0.05 8 weeks 0.69 29% p < 0.05Conventional Hair Growth Retardation Product Baseline 1.09 2 weeks 0.9414% p > 0.05 4 weeks 0.93 15% p > 0.05 8 weeks 0.88 20% p < 0.05 ControlBaseline 1.12 2 weeks 1.12  0% p > 0.05 4 weeks 1.19  −6%   p > 0.05 8weeks 1.12  0% p > 0.05

As can be seen in Table 4 above and corresponding FIG. 4, the hairgrowth retardation product incorporating the inventive compositionreduces hair growth by 29% after 8 weeks of use, as opposed to 20%reduction with the conventional hair growth retardation product and 0%using the control.

EXAMPLE 3 Comparative Study

The following example provides a clinical study comparing the inventivecomposition with the combination of ornithine decarboxylase inhibitor,anti-angiogenic active and an anti-inflammatory and the alteranateembodiment including the 5 alpha reductase inhibitor in retarding hairgrowth.

Formation of Study Panel:

Adult men who were interested in taking part in this study wererecruited from a local population. The following criteria for inclusionand exclusion were based on the information obtained from the candidatesand from an examination of the area that was involved in the study.

Inclusion Criteria: To be considered as a potential subject, eachcandidate must have:

-   -   a 5 o'clock shadow        Exclusion Criteria: A prospective participant is excluded if the        interview or examination disclosed any of the following:    -   a systemic illness that contra-indicates participation;    -   any dermatological disorders in the areas that were to be used        in the study; or    -   uses systemic or topical retinoids, antihistamines or similar        agents.        Composition of Panel:

The panel is composed of 27 men who satisfy all the requirementsitemized in the list of inclusion and exclusion criteria.

Test Products:

-   Group 1: Inventive composition with 0.1% 5 alpha reductase    inhibitor, saw palmetto.-   Group 2: Inventive composition without 5 alpha reductase inhibitor.    Method of Application:    Procedure for Shaving:

The panelists are instructed to report for all visits with a 24 hourbeard growth. The men then shave with their own razor and shaving cream.Measurements are taken immediately after shaving, and after 8 and 24hours.

The men are instructed to apply the product to their face two times aday, morning and evening, for 8 weeks. On the day of testing, the men donot apply the products for at least 12 hours before measurements weretaken. Product use is monitored by a daily diary as well as assessmentof remaining package content at the end of the study.

Clinical Test Procedure:

This is a double blinded controlled study consisting of eight weeksproduct use. The test site is the face. The men refrain from using anytreatment products on the test sites except for the test productsprovided. The panelists are instructed to report to the testing centerwith at least a 24 hour beard growth. Evaluations are carried out beforeproduct application (baseline), and after four, and eight weeks duringthe course of treatment.

Test Procedure:

1. Reduction of Hair Growth

At the outset of the study a particular area on the face of eachpanelist is marked. The images of that specific portion of the face areobtained using a Fuji S-2 Digital Camera with a Canfield epilumeadaptation. The Canfield Epilume allows for close up contact photos tobe taken at a fixed distance. The same area is photographed immediately,8 hours, and 24 hours after shaving at each visit. The stored images aredigitized and analyzed using an image analysis program, Optimas 6.51.

Shave Time—

At each time point the men use an electronic timer to measure the lengthof time needed to shave.

Self Evaluations—

A self evaluation is performed by each panelist on the appearance oftheir beard, 8 and 24 hours after shaving. The following 10 point analogscale is used: 0 10 Not Noticeable Extremely Noticeable

2. Results of Hair Retardation TABLE 5 Panelists Assessment HairRetardation of Beard Appearance Shave 8 hours 24 hours 5 hours 24 hoursTime Group 1 Inventive Composition with 5 alpha reductase inhibitor 4weeks 30% 29% 24% 21% 15% 8 weeks 47% 39% 30% 27% 20% Group 2 InventiveComposition without 5 alpha reductase inhibitor 4 weeks 17% 27% 19% 15% −6%   8 weeks 25% 38% 23% 19%  1%

As can be seen in Tables 4 and 5 above, after eight weeks of product usewith the composition containing the 5 alpha reductase inhibitor,panelists experienced a 47% reduction in hair growth eight hours aftershaving, as compared to a 17% reduction without the addition of the 5alpha reductase inhibitor in the product. Reduction in the appearance ofhair growth was 30% with the 5 alpha reductase inhibitor in the productand 23% without, eight hours after shaving.

It should be understood that the specific forms of the invention hereinillustrated and described are intended to be representative only.Changes, including but not limited to those suggested in thisspecification, may be made in the illustrated embodiments withoutdeparting from the clear teachings of the disclosure. Accordingly,reference should be made to the following appended claims in determiningthe full scope of the invention.

1. A cosmetic composition comprising: an ornithine decarboxylaseinhibitor; an anti-angiogenic active; an anti-inflammatory; and acosmetically acceptable vehicle.
 2. The cosmetic composition of claim 1wherein the ornithine decarboxylace inhibitor is a pentacyclictriterpene selected from the group consisting of ursolic acid, betulin,betulinic acid, oleanolic acid, betulin mono and di-succinate orglutarate and polyethylene glycol and wherein the ornithinedecarboxylace inhibitor is present in an amount from 0.1% to 50%.
 3. Thecosmetic composition of claim 1 wherein the anti-angiogenic active is asphingo lipid selected from the group consisting of phytosphingosine,dihydrosphingosine, sphingosine and dehydrosphingosine and wherein theanti-angiogenic active is present in an amount of from 0.01% to 10%. 4.The cosmetic composition of claim 1 wherein the anti-angiogenic activeis selected from the group consisting of magnolia extract, sharkcartilage and tetrahydrocurcumin.
 5. The cosmetic composition of claim 1wherein the anti-inflammatory is selected from the group consisting ofgorgonian extract, hoelen extract, ximenynic acid, hesperitin, teapolyphenols and licorice extract and wherein the anti-inflammatory ispresent in an amount from 0.0001% to 20%.
 6. The cosmetic composition ofclaim 1 further comprising a whitening agent selected from the groupconsisting of yeast extract, ferulic acid, vitamin C derivatives, Na+hinokitiol, licorice extract, extracts of mitracarpus scaber/bearberry,extracts of mulberry/scutellaria, arbutin, resveratrol and kojic acid.7. The cosmetic composition of claim 1 further comprising a plantextract selected from the list consisting of soy extract, wild yarn andginseng.
 8. The cosmetic composition of claim 1 further comprising a 5alpha reductase inhibitor selected from the group consisting of sawpalmetto, woodworm (Artemisinin), liposome encapsulated azuleic acid(Azelosome), clove extract (Chouji Liquid), Zinc salt of L-PyrrolidoneCarboxylic Acid (Zincidoneg), mixture of water, hydrolyzed soy protein,3-aminopropane, sulfonic acid and sodium chondroitin sulfate (Capigen),seaweed extract (Phlorogine), isolutrol, progesterone,(5,20-R)-4-diazo-21-hydroxy-20-methyl pregnan-3-one,(4R)-5-10-seco-19-Norpregna4,5-diene-3,10,20 trione,4-androstene-3-one-17-carboxylic acid, and its methyl ester,17-beta-N,N-diethylcarbamoyl-9-methyl-4-aza-5-alpha-androstane-3-one,11-alpha-OH-progesterone, 17-alpha-OH-progesterone, and20-alpha-OH-progesterone.
 9. A cosmetic composition comprising: from 0.1to 50% of a penticylic triterpene; from 0.01 to 10% of a sphingo lipid;from 0.0001 to 20% of gorgonian extract; and a cosmetically acceptablevehicle.
 10. The cosmetic composition of claim 9 wherein the pentacyclictriterpene is selected from the group consisting of ursolic acid,betulin, betulinic acid, oleanolic acid, betulin mono and di-succinateor glutarate and polyethylene glycol.
 11. The cosmetic composition ofclaim 9 wherein the sphingo lipid is selected from the group consistingof phytosphingosine, dihydrosphingosine, sphingosine anddehydrosphingosine.
 12. The cosmetic composition of claim 9 furthercomprising an anti-angiogenic active selected from the group consistingof magnolia extract, shark cartilage and tetrahydrocurcumin.
 13. Thecosmetic composition of claim 9 further comprising a whitening agentselected from the group consisting of yeast extract, ferulic acid,vitamin C derivatives, Na+ hinokitiol, licorice extract, extracts ofmitracarpus scaber/bearberry, extracts of mulberry/scutellaria, arbutin,resveratrol and kojic acid.
 14. The cosmetic composition of claim 9further comprising a plant extract selected from the group consisting ofsoy extract, wild yarn, and ginseng.
 15. The cosmetic composition ofclaim 9 further comprising a 5 alpha reductase inhibitor selected fromthe group consisting of saw palmetto, woodworm (Artemisinin), liposomeencapsulated azuleic acid (Azelosome), clove extract (Chouji Liquid),Zinc salt of L-Pyrrolidone Carboxylic Acid (Zincidone®), mixture ofwater, hydrolyzed soy protein, 3-aminopropane, sulfonic acid and sodiumchondroitin sulfate (Capigen), seaweed extract (Phlorogine), isolutrol,progesterone, (5,20-R)-4-diazo-21-hydroxy-20-methyl pregnan-3-one,(4R)-5-10-seco-19-Norpregna4,5-diene-3,10,20 trione,4-androstene-3-one-17-carboxylic acid, and its methyl ester,17-beta-N,N-diethylcarbamoyl-9-methyl-4-aza-5-alpha-androstane-3-one,11-alpha-OH-progesterone, 17-alpha-OH-progesterone, and20-alpha-OH-progesterone.
 16. A method for retarding the growth haircomprising applying a composition comprising from 0.1 to 50% of anornithine decarboxylase inhibitor; from 0.01 to 10% of ananti-angiogenic active; from 0.0001 to 20% of an anti-inflammatory; anda cosmetically acceptable vehicle.
 17. The method of claim 16 whereinthe ornithine decarboylace inhibitor is a pentacyclic triterpeneselected from the group consisting of ursolic acid, betulin, betulinicacid, oleanolic acid, betulin mono and di-succinate or glutarate andpolyethylene glycol.
 18. The method of claim 16 wherein theanti-angiogenic active is a sphingo lipid selected from the groupconsisting of phytosphingosine, dihydrosphingosine, sphingosine anddehydrosphingosine.
 19. The method of claim 16 wherein theanti-angiogenic active is selected from the group consisting of magnoliaextract, shark cartilage and tetrahydrocurcumin.
 20. The method of claim16 wherein the anti-inflammatory is selected from the group consistingof gorgonian extract, hoelen extract, ximenynic acid, hesperitin, teapolyphenols and licorice extract.
 21. The method of claim 16 wherein thecomposition further comprises a whitening agent selected from the groupconsisting of yeast extract, ferulic acid, vitamin C derivatives, Na+hinokitol, licorice extract, extracts of mitracarpus scaber/bearberry,extract of mulberry/scutellaria, arbutin, resveratrol and kojic acid.22. The method of claim 16 wherein the composition further comprises aplant extract selected from the group consisting of soy extract, wildyarn and ginseng.
 23. The method of claim 16 wherein the compositionfurther comprises a 5 alpha reductase inhibitor selected from the groupconsisting of saw palmetto, woodworm (Artemisinin), liposomeencapsulated azuleic acid (Azelosome), clove extract (Chouji Liquid),Zinc salt of L-Pyrrolidone Carboxylic Acid (Zincidone®), mixture ofwater, hydrolyzed soy protein, 3-aminopropane, sulfonic acid and sodiumchondroitin sulfate (Capigen), seaweed extract (Phlorogine), isolutrol,progesterone, (5,20-R)-4-diazo-21-hydroxy-20-methyl pregnan-3-one,(4R)-5-10-seco-19-Norpregna4,5-diene-3,10,20 trione,4-androstene-3-one-17-carboxylic acid, and its methyl ester,17-beta-N,N-diethylcarbamoyl-9-methyl-4-aza-5-alpha-androstane-3-one,11-alpha-OH-progesterone, 17-alpha-OH-progesterone, and20-alpha-OH-progesterone.
 24. A method of retarding hair growthcomprising applying a cosmetic composition comprising: from 0.1 to 50%of a penticylic triterpene; from 0.01 to 10% of a sphingo lipid; from0.0001 to 20% of gorgonian extract; and a cosmetically acceptablevehicle.
 25. The method of claim 24 wherein the pentacyclic triterpeneis selected from the group consisting of ursolic acid, betulin,betulinic acid, oleanolic acid, betulin mono and di-succinate orglutarate and polyethylene glycol.
 26. The method of claim 24 whereinthe sphingo lipid is selected from the group consisting ofphytosphingosine, dihydrosphingosine, sphingosine anddehydrosphingosine.
 27. The method of claim 24 wherein the compositionfurther comprises an anti-angiogenic active selected from the groupconsisting of magnolia extract, shark cartilage and tetrahydrocurcumin.28. The method of claim 24 wherein the composition further comprises awhitening agent selected from the group consisting of yeast extract,ferulic acid, vitamin C derivatives, Na+ hinokitol, licorice extract,extracts of mitracarpus scaber/bearberry, extract ofmulberry/scutellaria, arbutin, resveratrol and kojic acid.
 29. Themethod of claim 24 wherein the composition further comprises a plantextract selected from the group consisting of soy extract, wild yarn,and ginseng.
 30. The method of claim 24 wherein the composition furthercomprises a 5 alpha reductase inhibitor selected from the groupconsisting of saw palmetto, woodworm (Artemisinin), liposomeencapsulated azuleic acid (Azelosome), clove extract (Chouji Liquid),Zinc salt of L-Pyrrolidone Carboxylic Acid (Zincidone®), mixture ofwater, hydrolyzed soy protein, 3-aminopropane, sulfonic acid and sodiumchondroitin sulfate (Capigen), seaweed extract (Phlorogine), isolutrol,progesterone, (5,20-R)-4-diazo-21-hydroxy-20-methyl pregnan-3-one,(4R)-5-10-seco-19-Norpregna4,5-diene-3,10,20 trione,4-androstene-3-one-17-carboxylic acid, and its methyl ester,17-beta-N,N-diethylcarbamoyl-9-methyl-4-aza-5-alpha-androstane-3-one,11-alpha-OH-progesterone, 17-alpha-OH-progesterone, and20-alpha-OH-progesterone.